A Study of Intravenous Tamiflu (Oseltamivir) in Children With Influenza

NCT01033734 | Completed Phase 1 Results

• 1 other identifier: NP25139
• Study Type: interventional
• Target: 8
• Locations: 3 countries
• Sites: 38

Brief Summary

This open-label study will assess the pharmacokinetics/pharmacodynamics and safety of intravenous (iv) Tamiflu (oseltamivir) in 3 cohorts of children, aged 6-12, 3-5 and 1-2 years, with influenza infection. Patients will receive iv Tamiflu therapy for 5 days (10 doses). For patients whose conditions no longer merit continued iv dosing, therapy may be switched to oral Tamiflu to complete their prescribed course of treatment. If medically necessary, iv or oral therapy with Tamiflu may be continued for up to 5 additional days. Anticipated time on study treatment is 5 to 10 days.

Conditions

Influenza

Outcome Measures

Primary Outcomes (10)

• Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Plasma Concentration (AUClast) of Oseltamivir and Oseltamivir Carboxylate on Day 1

  Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion.

• AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 2

  Day 2: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion

• AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 3

  Day 3 (with or after fifth dose): 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion

• AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 4

  Day 4: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion

• AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 5

  Day 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion

• Maximum Observed Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate Day 1

  Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion

• Cmax of Oseltamivir and Oseltamivir Carboxylate Day 2

  Day 2: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion

• Cmax of Oseltamivir and Oseltamivir Carboxylate Day 3

  Day 3 (with or after fifth dose): 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion

• Cmax of Oseltamivir and Oseltamivir Carboxylate Day 4

  Day 4: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion

• Cmax of Oseltamivir and Oseltamivir Carboxylate Day 5

  Day 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion

Secondary Outcomes (7)

• Time to the Maximum Observed Plasma Concentration (Tmax) of Oseltamivir and Oseltamivir Carboxylate

  Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion

• Last Measurable Plasma Concentration (Clast) of Oseltamivir and Oseltamivir Carboxylate

  Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion

• Time of the Last Measurable Plasma Concentration (Tlast) of Oseltamivir and Oseltamivir Carboxylate

  Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion

• Elimination Rate Constant (ke) of Oseltamivir and Oseltamivir Carboxylate

  Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion

• Total Clearance of Drug (CL) of Oseltamivir and Oseltamivir Carboxylate

  Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion

Study Arms (1)

Single arm

EXPERIMENTAL

Drug: oseltamivir [Tamiflu]

Interventions

oseltamivir [Tamiflu] DRUG

5-day course (10 doses), intravenous administration, may be switched to oral administration at the discretion of the investigator; up to 5 additional days of treatment possible.

Single arm

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children, 1-12 years of age
• diagnosis of influenza
• duration of influenza symptoms \</=96 hours prior to first dose of study drug

You may not qualify if:

• evidence of severe hepatic decompensation
• patients taking probenecid within 1 week prior to first dose of study drug

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (38)

Unknown Facility

Los Angeles, California, 90095, United States

Location

Unknown Facility

Oakland, California, 94609-1809, United States

Location

Unknown Facility

Aurora, Colorado, 80045, United States

Location

Unknown Facility

Wilmington, Delaware, 19803, United States

Location

Unknown Facility

Jacksonville, Florida, 32209, United States

Location

Unknown Facility

Chicago, Illinois, 60611, United States

Location

Unknown Facility

South Bend, Indiana, 46601, United States

Location

Unknown Facility

Wichita, Kansas, 67214, United States

Location

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Louisville, Kentucky, 40202, United States

Location

Unknown Facility

Boston, Massachusetts, 02111, United States

Location

Unknown Facility

Boston, Massachusetts, 02115, United States

Location

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Boston, Massachusetts, 02118, United States

Location

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Springfield, Massachusetts, 01199, United States

Location

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Detroit, Michigan, 48201, United States

Location

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Duluth, Minnesota, 55805, United States

Location

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Omaha, Nebraska, 68131, United States

Location

Unknown Facility

Morristown, New Jersey, 07960, United States

Location

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Brooklyn, New York, 11203, United States

Location

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New York, New York, 10016, United States

Location

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Stony Brook, New York, 11794-8161, United States

Location

Unknown Facility

Syracuse, New York, 13210, United States

Location

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The Bronx, New York, 10461, United States

Location

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Durham, North Carolina, 27705, United States

Location

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Raleigh, North Carolina, 27610, United States

Location

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Akron, Ohio, 44308, United States

Location

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Cleveland, Ohio, 44106, United States

Location

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Dayton, Ohio, 45404, United States

Location

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Toledo, Ohio, 43606, United States

Location

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Toledo, Ohio, 43608, United States

Location

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Oklahoma City, Oklahoma, 73104, United States

Location

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Tyrone, Pennsylvania, 16686, United States

Location

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Providence, Rhode Island, 02903, United States

Location

Unknown Facility

Charleston, South Carolina, 29524, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

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Richmond, Virginia, 23298, United States

Location

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Madison, Wisconsin, 53792, United States

Location

Unknown Facility

Petah Tikva, 19202, Israel

Location

Unknown Facility

Beirut, 11-236, Lebanon

Location

Related Publications (1)

• Munoz FM, Anderson EJ, Deville JG, Clinch B, Kamal MA. Pharmacokinetics and safety of intravenous oseltamivir in infants and children in open-label studies. Int J Clin Pharmacol Ther. 2015 Jul;53(7):531-40. doi: 10.5414/CP202307.

  PMID: 26042486 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Oseltamivir

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Limitations and Caveats

Low number of participants enrolled in the study at the time that the study was terminated limits conclusions that can be derived from the study data.

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2009
• First Posted: December 16, 2009
• Study Start: December 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 24, 2016
• Results First Posted: August 24, 2016

Record last verified: 2016-07

Locations

IL (1); LE (1); US (36)